HAIFA, Israel--(BUSINESS WIRE)--Bonus BioGroup announces that first transplantation of its proprietary live bone grafts in human was performed successfully. The clinical trial is designed to treat deficient facial bone tissues, including upper and lower jawbone cavitations, by transplantation of live bone implants comprising of cells originating from patients' own fat tissue and manufactured in Bonus BioGroup's Manufacturing Facility.
The initial stages of the trial, aimed at successful incorporation of the bone graft within the patient's body, were accomplished in the first patient. These stages consisted of harvesting a fat tissue sample from the patient, transportation of the sample to Bonus BioGroup's manufacturing facility, extraction of cells from the sample tissue, cultivation of those cells required for the generation of the human bone graft, production of the live human bone graft, transportation of the graft back to the medical site and its transplantation into the patient.
As the manufactured live human bone graft originates in the fat sample of the patient receiving the graft, the company expects the graft to be fully tolerated, and to not induce any immunological rejection. Upon exposure to the newly-transplanted graft, the patient's immune system is predicted to recognize the biological similarity between the patients' body and the graft manufactured from the patient's own cells by Bonus BioGroup. It is therefore anticipated that graft rejection - a frequent phenomenon in foreign donor tissue transplantation – shall be avoided.
The manufacturing process of Bonus BioGroup's viable human bone graft started with the collection of a fat tissue sample from the first patient, in the medical site. The fat tissue sample was transported within several hours to Bonus BioGroup's manufacturing facility where cells required for the bone graft production were extracted from the sample tissue and the generation of a transplantable and personalized live human bone graft began. As transplantation time approached, the ready-to-use graft was transported to the medical site, where the procedure was performed shortly thereafter.
Bonus BioGroup produces live human bone grafts comprising of cells harvested from patients' own fat tissue, in a personalized medicine approach. Its novel proprietary technology for the manufacturing of these cells combines multiple disciplines, such as material and tissue engineering, biology and regenerative medicine.
Bonus BioGroup's manufacturing facility was designed and established in compliance with the European Good Manufacturing Practice (GMP) and meets all advanced therapy regulations in regard to the production of clinical-grade cellular products suitable for human therapy.
Shai Meretzki, CEO of Bonus BioGroup: "Years of research and development performed by Bonus BioGroup are now culminating in the first autologous transplantation of a human bone manufactured outside of the patient's body. This successful transplantation points to the company's aptitude to produce viable human implants in our manufacturing facility and to transplant them back into the patients. We very much look forward now to the next four months, during which we shall follow the healing process of the deficient bone until it is fully repaired."
In the upcoming weeks, Bonus BioGroup plans to obtain fat tissue samples from about 19 more patients and to utilize them within its clinical trial to repair the patients' various facial bone deficits. The company believes that initial results pertaining to the extent of graft integration into the patient's bodies shall become available within four months of each transplantation, whereas the full clinical trial is expected to conclude within one year of transplantations.
The primary endpoint of this clinical trial is to evaluate the safety and efficacy of Bonus BioGroup's live human bone grafts.
